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FDA Proposes Reclassifying Hepatitis B Assays to Lower Risk Category

• The FDA is proposing to reclassify hepatitis B virus (HBV) assays from Class III (high risk) to Class II (moderate risk). • This change would allow HBV antigen, antibody, and nucleic acid-based assays to be eligible for the 510(k) clearance pathway. • The decision is based on the FDA's experience and postmarket data analysis, indicating a good safety record for these assays. • Special controls related to labeling and design verification are proposed to mitigate potential risks like false readings and misinterpretations.

Genentech's Gazyva Shows Positive Phase III Results in Lupus Nephritis Treatment

  • Genentech's Gazyva met its primary endpoint in a Phase III REGENCY study, demonstrating statistically significant benefits for lupus nephritis patients.
  • Patients treated with Gazyva plus standard therapy achieved a higher rate of complete renal response at 76 weeks compared to standard therapy alone.
  • The study also showed statistically significant improvements in secondary endpoints, including reduced corticosteroid use and improved proteinuric response.
  • Gazyva targets disease-causing B cells, potentially preventing or delaying progression to end-stage kidney disease in lupus nephritis patients.

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

NCT04861259Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/22/2021

Obinutuzumab in Primary MN

NCT05050214Active, Not RecruitingPhase 2
Mario Negri Institute for Pharmacological Research
Posted 2/18/2022

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

NCT04958265Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/17/2021

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus

NCT05155345CompletedPhase 1
Hoffmann-La Roche
Posted 1/11/2022

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

NCT05627557Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 3/29/2023

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants

NCT05039619RecruitingPhase 2
Hoffmann-La Roche
Posted 5/12/2022

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

NCT04221477Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 8/10/2020

Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus

NCT06400537RecruitingPhase 1
Wuhan Union Hospital, China
Posted 7/20/2024

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

NCT05797610RecruitingPhase 3
Hoffmann-La Roche
Posted 8/8/2023

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

NCT02550652CompletedPhase 2
Hoffmann-La Roche
Posted 11/13/2015

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

NCT04963296Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/26/2021

AstraZeneca and Immunai Collaborate to Enhance Oncology Clinical Trials with AI

  • AstraZeneca is partnering with Immunai to leverage AI for optimizing oncology clinical trials, focusing on improving decision-making processes.
  • The collaboration will utilize Immunai's AI platform to refine dose selection, understand mechanisms of action, and identify predictive biomarkers.
  • Immunai will receive $18 million for the initial phase, with potential for AstraZeneca to expand the collaboration's scope and duration.
  • This partnership aims to enhance the efficiency of bringing new therapies to patients by leveraging AI to improve clinical trial outcomes.

Optimizing Kidney Cancer Treatment: Keytruda, Inlyta, and Novel Approaches for Non-Clear Cell RCC

  • Considerations for discontinuing Keytruda (pembrolizumab) and Inlyta (axitinib) after two years involve balancing recurrence risk and side effects, necessitating individualized patient-physician discussions.
  • For non-clear cell chromophobe renal cell carcinoma, IO-TKI combinations like Lenvima (lenvatinib) plus Keytruda or Cabometyx (cabozantinib) plus Opdivo (nivolumab) show promise, with treatment choice depending on approval status.
  • Managing fatigue and chronic kidney disease in RCC patients requires investigating reversible causes and employing supportive measures, with nephrologist involvement for significant renal impairment.

FDA Approvals for Breast Cancer Drugs: Clinical Benefits, Development Time, and Pricing Analysis

  • The FDA approved 26 unique cancer drugs for breast cancer across 42 indications between 2000 and 2023, with a median development time of 7.8 years.
  • A meta-analysis of RCTs showed new breast cancer indications significantly reduced the likelihood of death (HR 0.78) and improved median OS by 2.8 months.
  • There was a weak correlation between OS and PFS, suggesting that improvements in PFS may not always translate to better OS or QoL.
  • Drug prices averaged $16,013 per month in 2023, with no significant correlation between price and clinical benefits like OS or QoL improvements.

LUNAR Trial Update: Tisotumab Vedotin Shows Promise in Advanced NSCLC

  • Updated analysis of the Phase 3 LUNAR trial reinforces tisotumab vedotin's potential as a treatment for advanced non-small cell lung cancer (NSCLC).
  • The study highlights clinically meaningful improvements in overall survival and progression-free survival in previously treated NSCLC patients.
  • Researchers presented these findings at the IASLC 2024 World Conference on Lung Cancer, sparking discussions about integrating tisotumab vedotin into treatment paradigms.

India Introduces New Regulations for Clinical Research Organizations

  • The Indian government has established Standard Operating Procedures (SOPs) for Clinical Research Organizations (CROs) to ensure the safety and quality of clinical trials.
  • The new regulations, under the New Drugs and Clinical Trials (Amendment) Rules, 2024, define the roles, duties, and liabilities of CROs, effective April 1, 2025.
  • CROs must now apply to the Central Licensing Authority for registration to conduct clinical trials or bioavailability/bioequivalence studies, enhancing transparency and oversight.
  • The government aims to improve product quality, expedite clinical trials for new medications and vaccines, and create a repository of organizations involved in clinical research.

Donanemab Approved in US for Early Alzheimer's Treatment, UK Approval Uncertain

  • The FDA approved donanemab in July 2024 for early symptomatic Alzheimer's, including mild cognitive impairment and mild dementia.
  • Clinical trials showed donanemab slowed cognitive decline by approximately 22% compared to placebo over 18 months.
  • UK approval is uncertain, with NICE potentially rejecting it due to high costs relative to modest benefits, following a similar decision on lecanemab.
  • Donanemab, developed by Eli Lilly, awaits UK approval, but sources suggest NICE may reject it due to cost concerns.

Glofitamab-gxbm (Columvi) Approved for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

  • Glofitamab-gxbm, a CD20xCD3 T-cell engaging bispecific antibody, is approved for relapsed or refractory diffuse large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
  • The accelerated approval was based on a phase 1/2 study showing a 56% response rate and a median duration of response of 18.4 months in treated patients.
  • Glofitamab-gxbm is administered intravenously over a fixed duration, with premedication to reduce the risk of cytokine release syndrome (CRS) and infusion-related reactions.
  • Adverse events include CRS and Immune effector cell–associated neurotoxicity syndrome (ICANS), requiring careful monitoring and management in equipped facilities.

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

NCT03075696RecruitingPhase 1
Hoffmann-La Roche
Posted 2/21/2017

Wegovy Shows Promise in Treating Hidradenitis Suppurativa

  • A study at St Vincent’s University Hospital found that Wegovy (semaglutide) reduced flare-up frequency in hidradenitis suppurativa (HS) patients with obesity.
  • Patients receiving Wegovy experienced a reduction in flare-up frequency from once every 8.5 weeks to once every 12 weeks, alongside improved quality of life.
  • The study also noted weight loss among patients, with average BMI decreasing from 43.1 to 41.5 and a third of patients losing 10kg or more.
  • Lead researcher Dr. Daniel Lyons suggests semaglutide, even at modest doses, offers substantial benefits in managing HS, warranting larger randomized controlled trials.

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